Application 018671
- Type
- NDA
- Sponsor
- CARDINAL HEALTH 418
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 100uCi | Yes | Yes |
| 002 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 200uCi | Yes | Yes |
| 003 | SODIUM IODIDE I 123 | SODIUM IODIDE I-123 | CAPSULE;ORAL | 400uCi | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 48815-1001 | Sodium Iodide I 123 | Sodium Iodide I 123 | Cardinal Health 418, Inc | NDA | Current |
| 48815-1002 | Sodium Iodide I 123 | Sodium Iodide I 123 | Cardinal Health 418, Inc | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 33552 | SUPPL | 2008-06-18 |
| 15085 | SUPPL | 2008-06-17 |